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Satoreotide Tetraxetan

Clinical trials of Satoreotide Tetraxetan are studying long-term safety in people with somatostatin receptor positive neuroendocrine tumours. The main goal is to see whether second primary cancers appear after treatment. This article summarizes the trial purpose, phase, target group, and main outcome being measured.

Table of contents

Trial overview

The source data include one clinical trial of Satoreotide Tetraxetan.[1] It was a multicentre surveillance study, which means it followed participants at more than one study site to watch for safety problems over time.[1]

The study was designed to evaluate long-term safety in people who had already been treated with 177Lu-IPN01072 in an Ipsen-sponsored clinical study.[1] Its brief summary says the goal was to assess the incidence of second primary haematological and non-haematological malignancies.[1]

Who was studied

The trial focused on participants with somatostatin receptor positive neuroendocrine tumours (NETs).[1] This means the tumour type in the study had a specific receptor marker that matched the trial’s eligibility group.[1]

The enrollment was very small, with only 3 participants.[1] Because of this, the study is best understood as a focused safety follow-up rather than a large treatment trial.[1]

Study design and phase

This was an interventional study in Phase 3.[1] Interventional means the study involved a treatment or study intervention rather than only observation.[1]

The status of the study was Completed.[1] The record also shows that the intervention included Satoreotide Tetraxetan Lutetium-177 and Satoreotide Tetraxetan given intravenously at 7.4 GBq.[1]

What was measured

The main outcome was the presence of participants with second primary haematological and non-haematological malignancies.[1] In simple terms, the study looked for new cancers that started separately from the original disease.[1]

Haematological malignancies are cancers of the blood or blood-forming tissues, while non-haematological malignancies are cancers outside the blood system.[1] This outcome shows that the study was checking for long-term safety concerns after earlier treatment.[1]

What the trial data show

Based on the trial record, the main purpose was surveillance for second primary cancers after prior treatment, not testing whether the treatment worked against tumour growth.[1] The study was small, with only 3 participants, so the data are limited and mainly describe follow-up safety in a specific patient group.[1]

For patients reading this trial record, the key point is that Satoreotide Tetraxetan was studied in a narrow group of people with receptor-positive NETs and the researchers were mainly watching for long-term safety signals.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05017662Phase 3Somatostatin receptor positive neuroendocrine tumours (NETs)Completed3

FAQ

  • Who could join the Satoreotide Tetraxetan trial? The study included people with somatostatin receptor positive neuroendocrine tumours who had been treated before in an Ipsen-sponsored clinical study. Only a very small group was enrolled.
  • What was the trial trying to find out? The trial was checking long-term safety. The main question was whether participants developed second primary cancers, meaning a new cancer that is different from the original one.
  • What phase was this study? This was a Phase 3 study. Phase 3 trials usually look at larger questions about safety and benefit in a defined patient group, but this study had only 3 participants.
  • What condition was studied? The condition studied was somatostatin receptor positive neuroendocrine tumours, often called NETs. These are the cancer type described in the trial record.
  • What was the main endpoint? The main endpoint was the presence of participants with second primary haematological and non-haematological malignancies. This means the study looked for new blood cancers and new cancers outside the blood.

Igangværende kliniske forsøg for Satoreotide Tetraxetan

  • Langtidsopfølgning af patienter med neuroendokrine tumorer efter behandling med 177Lu-IPN01072 for at undersøge sikkerheden

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

Ordliste

  • Neuroendokrine tumours (NETs): A type of cancer described in the trial record. The study focused on NETs that were positive for somatostatin receptors.
  • Somatostatin receptor positive: This means the tumour has a specific marker on its cells that the study used to identify eligible participants.
  • Phase 3: A later stage of clinical research that usually checks safety and possible benefit in people with the condition.
  • Interventional study: A trial in which participants receive a study treatment or intervention, rather than only being observed.
  • Long-term safety: How safe a treatment appears over a longer period of time, not just right after treatment.
  • Second primary malignancy: A new cancer that starts separately from the original cancer.
  • Haematological malignancy: A cancer of the blood or blood-forming tissues.
  • Non-haematological malignancy: A cancer that does not start in the blood or blood-forming tissues.
  • Intravenous administration: Treatment given through a vein.
  • Enrollment: The number of participants who joined the study.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/langtidsopfolgning-af-patienter-med-neuroendokrine-tumorer-efter-behandling-med-177lu-ipn01072-for-at-undersoge-sikkerheden/